Highly active antiretroviral therapy (HAART) has improved the long time survival of HIV infected individuals. However an increasing number of HIV-patients have developed metabolic and morphological alterations including peripheral lipoatrophy.

There is limited knowledge about lipodystrophic adverse events in nucleoside reverse transcriptase inhibitor (NRTI)-sparing regimens. The hypothesis is that nucleoside analogues are responsible for development of lipoatrophy, and, patients receiving an NRTI-sparing regimen will have little risk of peripheral lipoatrophy.

The researchers plan to perform a randomized study recruiting 100 antiretroviral naive patients that will be randomized to receive a nucleoside analogue sparing HAART regimen or a protease-inhibitor sparing regimen.

The main endpoint is changes in peripheral fat mass as determined by dual energy X-ray absortiometry (DEXA)-scanning.

Comparing a Nucleoside-Analogue-Sparing Regimen and a Protease-Inhibitor-Sparing Regimen in Patients With HIV. Influence on Morphological and Metabolic Disorders. A Randomized, Open-Label Multicenter Trial.

Proportion of patients who have virological, immunological or clinical failure or treatment-limiting adverse events at week 24, 48 and 96

Change in plasma lactate from baseline

Time to discontinuation of the randomized therapy and reasons for this

Incidence of genotypical and virological resistance

Development of osteopenia, judged by DEXA-scan

Compliance – proportion of patients who report to take 90%, respectively 95% of their medications at week 4, 48 and 96

Estimated Enrollment:

100

Study Start Date:

June 2003

Estimated Study Completion Date:

November 2007

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Antiretroviral naïve patients

HIV-1 infection as documented by a licensed HIV-1 antibody ELISA.

Fulfilling the criteria for starting antiretroviral therapy.

Ability to understand and provide written informed consent.

Exclusion Criteria:

Women being pregnant or breast-feeding.

Fertile women using no safe contraception.

Patients with active intravenous drug use.

Abuse of alcohol, which in the opinion of the treating physician will reduce the patient´s ability to follow a therapeutic regimen and evaluations of the protocol.

Ongoing medical treatment, which has a clinically significant interaction with lopinavir, ritonavir or efavirenz.

Creatinine > 200 mmol/l.

ALT or AST > 5 times upper normal value (200U/l).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135460

Locations

Denmark

Department of Infectious Diseases, Hvidovre University Hospital

Hvidovre, Copenhagen, Denmark, 2650

Department of Infectious Diseases, Aalborg Hospital

Aalborg, Denmark

Department of Infectious Diseases, Aarhus University Hospital

Aarhus, Denmark, 8200

Department of Infectious Diseases, Rigshospitalet

Copenhagen, Denmark, 2100

Department of Infectious Diseases, Odense University Hospital

Odense, Denmark, 5000

Sponsors and Collaborators

Danish HIV Research Group

Rigshospitalet, Denmark

Hvidovre University Hospital

Odense University Hospital

Aarhus University Hospital

Aalborg Universitetshospital

Abbott

Investigators

Study Chair:

Jan Gerstoft, M.D., DMSc

Rigshospitalet, Denmark

Principal Investigator:

Niels Obel, M.D., DMSc

Odense University Hospital

Principal Investigator:

Court Pedersen, Professor

Odense University Hospital

Principal Investigator:

Lars Mathiesen, M.D.,DMSc

Hvidovre University Hospital

Principal Investigator:

Henrik Nielsen, M.D.,DMSc

Aalborg Universitetshospital

Principal Investigator:

Alex Laursen, M.D., DMSc

Aarhus University City

Principal Investigator:

Ann-Brit E Hansen, M.D.

Copenhagen University Hospital Rigshospitalet and Odense University Hospital